Wearable ultrafiltration device

• US 7,645,253 B2
• Filed: 05/14/2004
• Issued: 01/12/2010
• Est. Priority Date: 11/16/2001
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: National Quality Care Inc.
• Inventors: Gura, Victor, Rambod, Edmond
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US10/846,618
• Publication Number:
  US 20040254514A1
• Time in Patent Office: 2,069 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/29, 604/361, 604/358, 604/327, 210/645, 210/646, 210/739, 210/195.2, 210/433.1, 210/500.1, 422/44
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3382 Upper level detectors
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: B01D 2313/243 Pumps
• CPC Class Codes: B01D 2321/2066 Pulsated flow
• CPC Class Codes: B01D 61/145 Ultrafiltration

Abstract

An ultrafiltration device adapted to be worn on a portion of the body of a patient includes a blood inlet tube leading from a first blood vessel, a blood pump, an anticoagulant reservoir for infusing anticoagulants into the blood, a blood filter including a substrate through which the blood is circulated and filtered, a fluid bag for storing the excess fluid and a blood outlet tube leading to a second blood vessel.

Claims

1. A portable, wearable ultrafiltration device comprising:

a blood inlet for receiving blood flow from a patient;

a pulsatile blood pump connected to the blood inlet, the pulsatile pump configured to pump blood from the patient in a pulsatile manner through the ultrafiltration device at a flow rate between 10 and 70 ml/min.;

a blood filter for filtering excess body fluid from said blood, the blood filter including a filter inlet connected to the pulsatile blood pump and a fixed semiporous filter material having a first surface in contact with the patient'"'"'s blood and a second surface on which fluid from the patient'"'"'s blood is received, the pulsatile pump pumping the patient'"'"'s blood to and through the filter with sufficient pressure to force fluid from the blood through the semiporous filter material, the blood filter having a blood side and a fluid side configured so that the only fluid on the fluid side of the blood filter is fluid separated from the blood passing through the blood side of the blood filter, the rate of fluid separation from the blood is configured to be adjusted by a combination of the flow rate being between 10 and 70 ml/min and by variably controlling a continuous fluid flow from the blood filter;

a blood outlet connected to the blood filter, the blood outlet receiving blood from the blood filter and conducting the blood back to the patient; and

a fluid bladder including a bladder inlet connected to the fluid side of the blood filter, the fluid bladder receiving and collecting fluid from the fluid side of the blood filter, the wearable ultrafiltration device constructed and configured to operate while in various three-dimensional orientations on the body of the patient.

2. The portable, wearable ultrafiltration device of claim 1 wherein the device weighs less than five (5) pounds.

3. The portable, wearable ultrafiltration device of claim 1 wherein the pulsatile pump pumps blood through the filter in a pulsed manner at a flow rate of between 15 and 200 ml/min.

4. The portable, wearable ultrafiltration device of claim 1, further comprising:

an anticoagulant reservoir; and

a first micropump for pumping anticoagulant from said anticoagulant reservoir into said blood at a location between said blood inlet and said blood filter.

5. The portable, wearable ultrafiltration device of claim 1, further comprising a microcontroller programmed to control said pulsatile pump flow rate and a variable continuous fluid flow from the blood filter.

6. The portable, wearable ultrafiltration device of claim 5, further comprising a moisture sensor inside a covering about said ultrafiltration device, said moisture sensor providing a moisture signal to said microcontroller when moisture is sensed inside said covering.

7. The portable, wearable ultrafiltration device of claim 6, wherein said microcontroller provides a signal that turns said pulsatile pump off after receiving said moisture signal when moisture is sensed inside said covering.

8. The portable, wearable ultrafiltration device of claim 5, further comprising a bladder sensor for sensing a fullness of said fluid bladder, said bladder sensor configured to provide a full signal to said microcontroller when said bladder sensor senses that said fluid bladder is full.

9. The portable, wearable ultrafiltration device of claim 5, further comprising a battery device configured to power the wearable ultrafiltration device continuously for at least six to twenty-four hours.

10. The portable, wearable ultrafiltration device of claim 1, wherein said fluid bladder contains an absorbent material that reduces the movement of the fluid within said fluid bladder.

11. A portable, wearable ultrafiltration device comprising:

a blood inlet for receiving blood flow from a patient;

a pulsatile pump connected to the blood inlet for pumping blood from the blood inlet to and through the ultrafiltration device, the pulsatile pump establishing an adjustable pulsed blood flow rate of between 10 and 200 ml/min;

a blood filter for filtering an ultrafiltrate fluid from said blood, the blood filter including a filter inlet connected to the pulsatile blood pump and a fixed semiporous filter material having a first surface in contact with the patient'"'"'s blood and a second surface on which ultrafiltrate fluid from the patient'"'"'s blood is received, the pulsatile pump configured to pump the patient'"'"'s blood through the filter with sufficient pressure to force excess body fluid from the blood through the semiporous filter material, the blood filter having a blood side and a fluid side configured such that the only fluid on the fluid side of the blood filter is ultrafiltrate fluid separated from the blood passing through the blood side of the blood filter, the rate of ultrafiltrate removal being both continuous and adjustable by a combination of varying the blood flow rate between 10 and 200 ml/min and by controlling a continuous and variable ultrafiltrate flow from said blood filter,

a blood outlet for returning said blood to said patient; and

a fluid reservoir configured to receive said ultrafiltrate fluid from said blood filter and for temporarily storing said ultrafiltrate fluid;

said ultrafiltration device configured to operate while in various three-dimensional orientations.

12. The portable, wearable ultrafiltration device of claim 11 further comprising a pump having an inlet connected to the fluid side of the blood filter and an outlet connected to the fluid reservoir, the pump pumping ultrafiltrate fluid from the blood filter to the fluid reservoir.

13. The portable, wearable ultrafiltration device of claim 11 further comprising an anticoagulant reservoir;

and

a micropump, the micropump pumping anticoagulant from said anticoagulant reservoir into the blood before the blood enters the blood filter.

14. The portable, wearable ultrafiltration device of claim 13 wherein the micropump pumps anticoagulant from the anticoagulant reservoir into the blood at a location between said blood pump and the blood filter.

15. The portable, wearable ultrafiltration device of claim 11 wherein the blood filter comprises a plurality of miniaturized blood filters connected in series.

16. The portable, wearable ultrafiltration device of claim 11 wherein the blood filter comprises a plurality of miniaturized blood filters connected in parallel.

17. The portable, wearable ultrafiltration device of claim 11 wherein the pulsatile pump further comprises a double channel pulsatile pump.

18. A portable, wearable ultrafiltration device comprising:

a blood inlet for receiving blood flow from a patient;

a battery device powered pulsatile blood pump connected to the blood inlet such that blood from the patient is pumped by the pulsatile pump through said ultrafiltration device;

a blood filter for filtering overload body fluid from said blood, the blood filter including a blood side and a fluid side, the blood side having a blood filter inlet connected to the pulsatile blood pump and a blood filter outlet, the fluid side having a fluid outlet, the blood filter further comprising a fixed semiporous filter material having a first surface on the blood side of the blood filter in contact with the patient'"'"'s blood and a second surface on the fluid side on which overload body fluid from the patient'"'"'s blood is received, the pulsatile pump configured to pump the patient'"'"'s blood through the filter with sufficient pressure to force overload body fluid from the blood through the semiporous filter material, the fluid side configured with no fluid inlet such that the only fluid on the fluid side of the blood filter is the overload body fluid separated from the blood that passes from the blood side of the blood filter to the fluid side of the filter through the semiporous filter material;

the blood filter outlet receiving blood from the blood filter and conducting the blood back to the patient; and

a fluid reservoir including a reservoir inlet connected to the blood filter and configured to receive the overload body fluid separated from the patient'"'"'s blood, said overload body fluid being removed from the patient'"'"'s blood at a continuous and an adjustable rate that can be varied by a combination of varying a pumping rate of the battery powered pulsatile pump and variably occluding a continuous overload body fluid flow from being received by the fluid reservoir;

the wearable ultrafiltration device being configured to operate while in various three-dimensional orientations while being completely worn on the body of the patient.

19. The portable, wearable ultrafiltration device of claim 18 wherein the semiporous filter material comprises a plurality of hollow fibers having fixed ends.